FDA Warns Manufacturer Involved in Valsartan Recall FDA Warns Manufacturer Involved in Valsartan Recall
FDA has notified Zhejiang Huahai Pharmaceuticals it is subject to an ongoing investigation and outlines'serious'manufacturing violations.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 13, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings. (Source: Food and Drug Administration)
Source: Food and Drug Administration - December 11, 2018 Category: American Health Source Type: news

WATCH: Recall involving blood pressure medications expanding
Drugmaker Mylan is recalling 104 lots of three medications that include Valsartan after testing found trace amounts of a carcinogen. (Source: ABC News: Health)
Source: ABC News: Health - December 8, 2018 Category: Consumer Health News Tags: WNT Source Type: news

Valsartan Blood Pressure Drug Recall Widens
The drugs were recalled because of trace amounts of an impurity, N-nitrosodiethylamine, or NDEA, which may cause cancer in humans, according to the International Agency for Research on Cancer. (Source: WebMD Health)
Source: WebMD Health - December 7, 2018 Category: Consumer Health News Source Type: news

More Blood Pressure Meds Recalled Due to Carcinogen
FRIDAY, Dec. 7, 2018 -- Over the past few months, numerous recalls of the popular heart drug valsartan have already occurred. Now, generics maker Mylan Pharmaceuticals is adding more products to the list. The recall involves 104 lots of three... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - December 7, 2018 Category: General Medicine Source Type: news

Mylan Expands Recall to All Unexpired Lots of Valsartan in US Mylan Expands Recall to All Unexpired Lots of Valsartan in US
The latest recall stems from NDEA contamination and includes 26 lots of amlodipine/valsartan tablets, 51 lots of valsartan tablets, and 27 lots of valsartan/hydrochlorothiazide tablets.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 6, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths). (Source: Food a...
Source: Food and Drug Administration - December 4, 2018 Category: Food Science Source Type: news

Mylan to recall all batches of blood pressure medicine valsartan in U.S.
Mylan NV said on Tuesday it is expanding a nationwide voluntary recall of its blood pressure medicine valsartan to include all lots, two weeks after it recalled select batches. (Source: Reuters: Health)
Source: Reuters: Health - December 4, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Mylan to recall all batches of blood pressure medicine in U.S.
Mylan NV said on Tuesday it is issuing a nationwide voluntary recall of all lots of its blood pressure medicine valsartan, expanding a recall of select batches initiated two weeks ago. (Source: Reuters: Health)
Source: Reuters: Health - December 4, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Statins are being overprescribed, study suggests
The risks of statins for primary prevention are greater than the benefits for many patients Related items fromOnMedica Withdrawn valsartan meds not linked to short-term cancer risk Direct oral anticoagulants as safe as warfarin after VTE Too few women take part in many CVD clinical trials Use of DPP-4 inhibitors associated with increased risk of IBD Metformin doesn ’t help HbA1c in teens with type 1 diabetes (Source: OnMedica Latest News)
Source: OnMedica Latest News - December 4, 2018 Category: UK Health Source Type: news

Teva Recalls Two Blood Pressure Medications
FRIDAY, Nov. 30, 2018 -- All lots of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination blood pressure tablets have been recalled by Teva Pharmaceuticals due to higher-than-acceptable levels of a chemical that may cause... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 30, 2018 Category: Pharmaceuticals Source Type: news

Class 2 Medicines Recall: Teva UK Limited and Mylan - recall of some Valsartan containing products
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a precautionary recall of all affected batches of Valsartan containing medicines made by Mylan and Teva UK Limited. This is du (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - November 30, 2018 Category: Drugs & Pharmacology Source Type: news

PIONEER: A Role for ARNI in Stabilized Acute HF? PIONEER: A Role for ARNI in Stabilized Acute HF?
Sacubitril/valsartan (Entresto) was studied in patients with acute decompensated heart failure in the PIONEER HF Trial. Dr Pi ñ a gets the details from lead investigator Eric Velazquez.theheart.org on Medscape (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 29, 2018 Category: Consumer Health News Tags: Cardiology Commentary Source Type: news

ARNI on Par With Other HFrEF Strategies for Saving Lives Long Term
(MedPage Today) -- Sacubitril/valsartan yields " comparable " number needed to treat at 5 years (Source: MedPage Today Primary Care)
Source: MedPage Today Primary Care - November 29, 2018 Category: Primary Care Source Type: news

Two More Valsartan Drugs Make Growing Recall List
All of the recalled products have ingredients manufactured in either China or India. The sudden rush of recalls because of ingredients made overseas has put more scrutiny on these foreign labs and on the FDA’s ability to effectively monitor their products for safety. (Source: WebMD Health)
Source: WebMD Health - November 28, 2018 Category: Consumer Health News Source Type: news

Another Valsartan Drug Makes Growing Recall List
All of the recalled products have ingredients manufactured in either China or India. The sudden rush of recalls because of ingredients made overseas has put more scrutiny on these foreign labs and on the FDA’s ability to effectively monitor their products for safety. (Source: WebMD Health)
Source: WebMD Health - November 28, 2018 Category: Consumer Health News Source Type: news

Teva Recalls All Amlodipine/Valsartan Combination Products in US Teva Recalls All Amlodipine/Valsartan Combination Products in US
In the ongoing saga of tainted sartans, Teva recalls all amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide combination products because of contamination with NDEA.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 27, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

Teva to recall certain blood pressure medicine in U.S
Teva Pharmaceutical Industries Ltd is recalling certain combinations of blood pressure drug valsartan in the United States following the detection of a probable cancer-causing impurity, the latest global recall of the medicine. (Source: Reuters: Health)
Source: Reuters: Health - November 27, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry
Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan ’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, a...
Source: Food and Drug Administration - November 27, 2018 Category: Food Science Source Type: news

Mylan Recalls 15 Lots of Valsartan Products in US Mylan Recalls 15 Lots of Valsartan Products in US
The Mylan recall of valsartan tablets, amlodipine/valsartan tablets, and valsartan/hydrochlorothiazide tablets marks the latest recall of sartans contaminated with probable carcinogens.News Alerts (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - November 21, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient
Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. These products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in...
Source: Food and Drug Administration - November 21, 2018 Category: Food Science Source Type: news

Mylan recalls batches of blood pressure medicine in U.S.
Mylan NV said on Tuesday it would recall certain batches of blood pressure medicine valsartan in the United States after they were found to contain a probable cancer-causing impurity, the latest recall amid heightened safety concerns globally. (Source: Reuters: Health)
Source: Reuters: Health - November 20, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Mylan recalls batches of blood pressure medicine in U.S
Drugmaker Mylan NV said on Tuesday it is recalling select batches of blood pressure medicine valsartan in the United States after they were found to contain trace amounts of a probable cancer-causing impurity. (Source: Reuters: Health)
Source: Reuters: Health - November 20, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

European authorities suspend Mylan's manufacturing license for hypertension drug
Mylan NV ’s manufacturing license for valsartan was suspended by European authorities after NDEA was found in some batches of the hypertension drug made at the company’s facility in Hyderabad, India, The European Medicals Agency said on Monday. Suspension of Mylan’s (Nasdaq: MYL) certificate of compl iance with European standards for quality testing effectively prohibits the use of its valsartan in EU medicines, EMA’s release said. NDEA in high doses is classified as a substance that could… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - November 20, 2018 Category: American Health Authors: Patty Tascarella Source Type: news

EU cracks down on blood pressure medicine made by Mylan
European Union authorities on Monday stepped in to effectively ban sales of blood pressure medicine valsartan made by an India-based unit of Mylan NV after some batches were found to contain a probable cancer-causing impurity, the latest in a global crackdown. (Source: Reuters: Health)
Source: Reuters: Health - November 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

European authorities crack down on blood pressure medicine made by Mylan
European Union authorities are cracking down on blood pressure medicine valsartan made by a unit of Mylan NV after an impurity was found in some batches of the treatment. (Source: Reuters: Health)
Source: Reuters: Health - November 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Blood Pressure Drug Recall Expands Again; Meds May Be Tainted With Cancer-Causing Chemical
(CNN) — The US Food and Drug Administration says another heart medicine is being voluntarily recalled after tests showed that it was tainted with a potential cancer-causing chemical. The recall includes one lot of Sandoz’s losartan potassium hydrochlorothiazide 100 milligram/25 milligram tablets with the lot number JB8912. Patients use these drugs to keep their high blood pressure in check. The drug is being recalled because the active ingredient has tested positive for N-Nitrosodiethylamine or NDEA, a suspected human and animal carcinogen that is used in gasoline as a stabilizer for industry materials and as a...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - November 12, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Consumer Health News Local TV Valsartan Source Type: news

PIONEER-HF: In-Hospital ARNI Shows Biomarker Benefit vs ACE-I PIONEER-HF: In-Hospital ARNI Shows Biomarker Benefit vs ACE-I
Prognostically powerful natriuretic peptides fell further in patients with stabilized, recently decompensated heart failure who were started in hospital on sacubitril/valsartan compared with enalapril.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 12, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

FDA Announces Recall Of Another Heart Medicine For Possible Cancer Risk
(CNN) — The US Food and Drug Administration is alerting patients of another recall of medicine used to treat high blood pressure, for a potential cancer risk due to contamination. This time, SciGen is recalling certain lots of irbesartan. The recalled lot will have “Westminster Pharmaceuticals” and “GSMS Inc.” on the label, according to the FDA list. Another heart medicine, valsartan, has also been recalled recently due to contamination. Irbesartan is an angiotensin II receptor blocker, or ARB. This is a drug that blocks a potent chemical in the blood called anigiotensin, which causes muscles ...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - November 1, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Local TV Recall Source Type: news

Treatment of hypertension for low-risk patients questioned
Study funds little evidence of benefits from treatment Related items fromOnMedica Withdrawn valsartan meds not linked to short-term cancer risk Avoid BP-lowering drugs in stroke Adding insulin to metformin linked to higher mortality Stroke rate higher in HIV patients Recurrent stroke more likely at very low BP (Source: OnMedica Latest News)
Source: OnMedica Latest News - November 1, 2018 Category: UK Health Source Type: news

FDA: Irbesartan Under Recall Too in the Midst of Valsartan Saga
(MedPage Today) -- Another ARB found to contain a potential carcinogen in some lots (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - October 31, 2018 Category: American Health Source Type: news

FDA Adds More Drugs To Valsartan Recall List
(CNN) — The US Food and Drug Administration again added to its list of products that are included in the recall of drugs containing valsartan, a generic ingredient that helps people with high blood pressure and heart failure. That ingredient in the recalled drugs was tainted with a possible carcinogen. The FDA testing of these products determined that an additional lot of brands sold under the name RemedyRepack needed to be added to the recall list. See The Full List Here (PDF) Several pills that contain valsartan have been under a voluntary recall since July. The drugs were tainted with N-nitrosodimethylamine, or ND...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - October 25, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Local TV Valsartan Source Type: news

The FDA again adds more drugs to its valsartan recall list
The US Food and Drug Administration again added to its list of products that are included in the recall of drugs containing valsartan, a generic ingredient that helps people with high blood pressure and heart failure. That ingredient in the recalled drugs was tainted with a possible carcinogen. (Source: CNN.com - Health)
Source: CNN.com - Health - October 25, 2018 Category: Consumer Health News Source Type: news

Cost of blood pressure drug surges in U.S. after recall
Prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States in September, following a recall of much of the drug's supply. (Source: Reuters: Health)
Source: Reuters: Health - October 16, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

EU places China's Zhejiang Huahai under increased supervision
European authorities are placing Zhejiang Huahai Pharmaceutical Co Ltd under higher supervision, the European Medicines Agency said on Monday, in the latest crackdown on the Chinese firm after a probable carcinogen was found in its blood pressure drug valsartan. (Source: Reuters: Health)
Source: Reuters: Health - October 15, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Is Sacubitril/Valsartan (Also) an Antiarrhythmic Drug? Is Sacubitril/Valsartan (Also) an Antiarrhythmic Drug?
Evidence suggests that sacubitril/valsartan may have antiarrhythmic effects. What does this mean for prevention of sudden death?Circulation (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - October 8, 2018 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Diovan HCT (Valsartan and Hydrochlorothiazide) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 3, 2018 Category: Drugs & Pharmacology Source Type: news

FDA Freezes Imports From Chinese Maker of Tainted Valsartan FDA Freezes Imports From Chinese Maker of Tainted Valsartan
The FDA's import alert bans all ingredients and finished drug products made by Zhejiang Huahai Pharmaceuticals from legally entering the United States.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - September 28, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

FDA Bans Import of Meds From Chinese Firm
The 'import alert' from the FDA against Zhejiang Huahai Pharmaceuticals comes after a series of recalls for valsartan heart and blood pressure drugs that include ingredients made by ZHP. (Source: WebMD Health)
Source: WebMD Health - September 28, 2018 Category: Consumer Health News Source Type: news

Losartan vs. Valsartan (Differences between Side Effects and Uses)
Title: Losartan vs. Valsartan (Differences between Side Effects and Uses)Category: MedicationsCreated: 9/21/2018 12:00:00 AMLast Editorial Review: 9/21/2018 12:00:00 AM (Source: MedicineNet Medications General)
Source: MedicineNet Medications General - September 21, 2018 Category: Drugs & Pharmacology Source Type: news

Safe to Start Sacubitril/Valsartan Predischarge in Acute HF Safe to Start Sacubitril/Valsartan Predischarge in Acute HF
In first of its kind data from the TRANSITION trial, patients safely tolerated the early-initiation strategy as well as the recommended practice of starting the uptitration process after discharge.Medscape Medical News (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 18, 2018 Category: Consumer Health News Tags: Cardiology News Source Type: news

Regulators find second cancer-linked chemical in recalled drug
A closer inspection of valsartan, a commonly used blood pressure medication, has uncovered traces of a second toxin. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - September 17, 2018 Category: Pharmaceuticals Source Type: news

FDA Finds Another Carcinogen in Certain Valsartan Heart Meds
Title: FDA Finds Another Carcinogen in Certain Valsartan Heart MedsCategory: Health NewsCreated: 9/14/2018 12:00:00 AMLast Editorial Review: 9/17/2018 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - September 17, 2018 Category: Cardiology Source Type: news

Daily aspirin not beneficial in healthy adults
Trial looks at risks and benefits of aspirin Related items fromOnMedica Too few women take part in many CVD clinical trials US doctor says FDA should have withdrawn rosuvastatin GPs defend practice on prescribing statins Drugs regulators “put profits before patients” Withdrawn valsartan meds not linked to short-term cancer risk (Source: OnMedica Latest News)
Source: OnMedica Latest News - September 17, 2018 Category: UK Health Source Type: news

FDA Finds Another Carcinogen in Certain Valsartan Heart Meds
FRIDAY, Sept. 14, 2018 -- The U.S. Food and Drug Administration warns that it has found a second impurity in three lots of Torrent Pharmaceuticals'valsartan drug products. The FDA first recalled valsartan medicines back in July, after the Chinese... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 14, 2018 Category: Pharmaceuticals Source Type: news

Second Contaminant Found in Valsartan Drugs
Those drugs were already part of August’s recall of valsartan products for possible contamination with NDMA, another impurity that may cause cancer. (Source: WebMD Health)
Source: WebMD Health - September 14, 2018 Category: Consumer Health News Source Type: news

No Early Cancer Risk Seen from Contaminated Valsartan
(MedPage Today) -- Cohort study reassures, but FDA notes a second contaminant (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - September 14, 2018 Category: American Health Source Type: news

FDA Finds Another Carcinogen in Certain Valsartan Heart Meds
FRIDAY, Sept. 14, 2018 -- There's more bad news for Americans who took certain brands of the common blood pressure medication valsartan. The U.S. Food and Drug Administration on Thursday warned that it has found a second impurity in three lots of... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - September 14, 2018 Category: General Medicine Source Type: news

No Short-Term Cancer Risk From Recalled Heart Med Valsartan: Study
Title: No Short-Term Cancer Risk From Recalled Heart Med Valsartan: StudyCategory: Health NewsCreated: 9/13/2018 12:00:00 AMLast Editorial Review: 9/14/2018 12:00:00 AM (Source: MedicineNet High Blood Pressure General)
Source: MedicineNet High Blood Pressure General - September 14, 2018 Category: Cardiology Source Type: news